Modern medical care often involves the use of medical pump devices to deliver substances, such as fluids and/or fluid medicine to patients. Medical pumps permit the controlled delivery of substances to a patient, and such pumps have largely replaced gravity flow systems, primarily due to the pump's much greater accuracy in delivery rates and dosages, and due to the possibility for flexible yet controlled delivery schedules.
A typical positive displacement pump system includes a pump device driver and a disposable fluid or pumping chamber, defined in various forms including but not limited to a cassette, syringe barrel or section of tubing. A disposable cassette, which is adapted to be used only for a single patient and for one fluid delivery round, is typically a small plastic unit having an inlet and an outlet respectively connected through flexible tubing to the fluid supply container and to the patient receiving the fluid. The cassette includes a pumping chamber, with the flow of fluid through the chamber being controlled by a plunger or pumping element activated in a controlled manner by the device driver.
For example, the cassette chamber may have one wall or wall portion formed by a flexible, resilient diaphragm or membrane that is reciprocated by the plunger and the driver to cause fluid to flow. The pump driver device includes the plunger or pumping element for controlling the flow of fluid into and out of the pumping chamber in the cassette, and it also includes control mechanisms to assure that the fluid is delivered to the patient at a pre-set rate, in a pre-determined manner, and only for a particular pre-selected time or total dosage.
The fluid enters the cassette through an inlet and is forced through an outlet under pressure. The fluid is delivered to the outlet when the pump plunger forces the membrane into the pumping chamber to displace the fluid. During the intake stroke the pump plunger draws back, the membrane covering the pumping chamber pulls back from its prior fully displaced configuration, and the fluid is then drawn through the open inlet and into the pumping chamber. In a pumping stroke, the pump plunger forces the membrane back into the pumping chamber to pressurize and force the fluid contained therein through the outlet. Thus, the fluid flows from the cassette in a series of spaced-apart pulses rather than in a continuous flow.
A fluid delivery line, such as a polymer tube which is well known in the art, is used with the medical pump devices to deliver the fluid from a fluid reservoir to the patient, such as through a catheter or needle connected to the fluid delivery line. In one prior medical pump, the medical pump included an air sensing arrangement having a transmitter and receiver for sensing air and/or air bubbles in the fluid delivery line. The transmitter is positioned within the pump at a location which is adjacent to a first side of the fluid delivery line when the fluid delivery line has been installed or mounted by a caregiver within the medical pump device. The receiver is positioned within the pump at a location which is adjacent to a second and opposite side of the fluid delivery line to the first side when the fluid delivery line has been installed or mounted by a caregiver within the medical pump device. The transmitter transmits an ultrasonic signal which travels through the fluid delivery line, and which is received by the receiver on the opposite side of the fluid delivery line from the transmitter. The signal transmitted by the transmitter and received by the receiver is modified or affected by the physical elements (the fluid delivery line, air within the fluid delivery line, fluid within the fluid delivery line, etc.) the signal encounters between the transmitter and the receiver.
In one medical pump system, disclosed in U.S. Pat. No. 6,142,008 to Cole et al., which is hereby incorporated by reference herein, while a motor actuates a pumping cassette, a controller controls the sampling by an air bubble sensor over a portion of the fluid delivery line. The controller determines whether each sample is either 100% air or 100% liquid by comparing a sampled signal from air bubble sensor to a predetermined threshold that is a fixed percentage of a last reading that was found to indicate the presence of liquid in fluid delivery line. If the sampled signal is valid and below the predetermined threshold, the controller determines that the sample indicates the presence of air. Conversely, if a valid sampled signal is above the predetermined threshold, the controller determines that the sample indicates the presence of a liquid in the distal tubing. The controller accumulates the volume associated with each sample as delta values used to determine the total liquid volume and the total air volume.
In this medical pump system, each sample is a representative approximation of the unsampled portion of distal tubing that precedes the current sampling, and the air sampling time intervals approximate the unsampled time intervals. The controller must determine a sampling time interval (in seconds) for continuous rotation of motor using a ratio of the motor's output drive shaft. For example, if the pumping cassette is pumping at high rates (e.g., 1000 ml/hr) and the sampling time interval is less than 40 milliseconds, the controller must set the sampling time interval, for example to 40 milliseconds. Further, if the pumping cassette is pumping at low rates (e.g., less than 126 ml/hr), the sampling time interval is set at 32 milliseconds, based on the ratio and other factors. Ideally, the sampling time interval begins when valves in the pumping cassette open and the interval ends when the valves close.
In this medical pump system, the controller turns off the power to air bubble sensor when the motor is not actuating the pumping cassette. In other words, the controller shuts down power to the air bubble sensor between each actuation of the pumping cassette, but leaves power to the air bubble sensor on during the actuation. When controller turns the power on to air bubble sensor, just prior to actuation beginning, approximately one millisecond of warm up time is needed before the sensor may be used. The controller checks the output signal from air bubble sensor for a false high when the associated amplification electronics are first turned on and when the transmitter of the air bubble sensor is not transmitting an ultrasonic pulse to the receiver of the air bubble sensor.
Equations are employed by controller for various functions, as described in this patent, including control of air bubble sensor, such as determining an air bubble sensor sampling rate, which is dependent on the flow rate and other variables. In addition, various logic flows are used to detect air in the fluid delivery line, and provide alarms when sufficient air is detected in the fluid delivery line. However, these equations and logic flows are based on a theory of operation which keeps the air bubble sensor powered on during the entire non-retraction portion or pressurization phase of each stroke.
Thus, it is a principal object of this invention to provide a medical pump and a method of operating a medical pump to overcome these deficiencies. The present invention is provided to solve the problems discussed above and other problems, and to provide advantages and aspects not provided by prior medical pumps.
As such, one object of the present invention includes reducing nuisance alarms.
One further object includes reducing dancing bubbles potentially resulting from ultra-sonic waves passing through the fluid delivery line, by reducing the amount of air detection sensor usage during pump operation, while at the same time providing for reliable air detection within the fluid delivery line.
One additional object includes reducing dancing bubbles potentially resulting from ultra-sonic waves passing through the fluid delivery line, by reducing the amount of air detection sensor usage during the delivery phase of pump operation, while at the same time providing for reliable air detection within the fluid delivery line.
One further object includes reducing bubble generation and/or small bubble accumulation/conglomeration potentially resulting from ultra-sonic waves passing through the fluid delivery line, by reducing the amount of air detection sensor usage during pump operation while at the same time providing for reliable air detection within the fluid delivery line.
One additional object includes reducing bubble generation and/or small bubble accumulation/conglomeration potentially resulting from ultra-sonic waves passing through the fluid delivery line, by reducing the amount of air detection sensor usage during the delivery phase of pump operation while at the same time providing for reliable air detection within the fluid delivery line.
One further object includes establishing robustness in the method and system of air detection using at least predetermined, adaptive and/or dynamic threshold selection according to empirical testing and/or delivery conditions at the time of actual delivery (i.e. tube type, fluid used, temperature, etc.)
One additional object includes intelligent and/or adaptive placement (when/where) of the first and subsequent air detection sensor “ping(s)” based times and/or angles of rotation (hard times and/or angles, and/or delays from a reference points) for one or more pumping mechanisms.
One further object includes using existing pump hardware technology and updating the software code to implement the system and method of the present invention.
One additional object includes reducing nuisance alarms resulting from dancing bubbles by, for example, using multiple air detection sensors to detect air bubbles in the fluid delivery line.
A full discussion of the features and advantages of the present invention is deferred to the following summary, detailed description, and accompanying drawings.